Cobalt sulphide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002-04-24

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cobalt sulphide

EC Number:

215-273-3

EC Name:

Cobalt sulphide

Cas Number:

1317-42-6

Molecular formula:

CoS

IUPAC Name:

Cobalt(2+) sulfide

Details on test material:

- Name of test material (as cited in study report): Cobalt sulphide
- Substance type: Gray powder
- Storage condition of test material: Store in a cool, well-ventilated place away from incompatible materials. In a dessicator under N2 atmosphere. At room temperature (20 ± 5 °C, provided by Harlan Laboratories Ltd.).

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard Teklad Global High Fiber Rabbit Diet 2031C (Provimi Kliba AG, 4303 Kaiseraugst / Switzerland)
- Water (e.g. ad libitum): Community tap water from Füllinsdorf
- Acclimation period: At least 5 days under laboratory conditions, after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): air-conditioned with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): automatically controlled light cycle of 12 hours light and 12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- The test item was applied at 0.1 g/animal, the dose specified in the test guidelines for solid test items.
- The eyes of the animals were examined one day prior to test item administration. Only those animals with no signs of ocular injury or irritation were used in the test.
- On the day of treatment, the test item was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then be gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the control.
- One animal was treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 1 hour and 24-hour examinations, the test was completed using the two remaining animals.

Duration of treatment / exposure:

not applicable

Observation period (in vivo):

approximately 1, 24, 48 and 72 hours as well as 7 days after test item instillation

Number of animals or in vitro replicates:

3 (1 male, 2 females)

Details on study design:

The eyes of the animals were examined one day prior to test item administration.

Observation and Scoring:
- The eye reactions were assessed according to the Draize scale. Scleral reddening and ocular discharge were also assessed according to following scale (See "Any other information on materials and methods incl. tables"). Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth
AG, 4153 Reinach / Switzerland).
- Viability / Mortality: Daily from acclimatization of the animals to the end of the observation period
- Clinical Signs (systemic): Daily from acclimatization of the animals to the end of the observation period
- Body Weights: At start of acclimatization, on the day of application and at the end of tbe observation period

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Results 6

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Results 9

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Results 10

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Results 11

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to Regulation (EC) No. 1272/2008 and subsequent regulations, cobalt sulphide is not classified as an eye irritant.